Biotherapeutics Analytical Summit

Following year over year success, CHI presents the Fifth Annual Biotherapeutics Analytical Summit, taking place March 24-28, 2014 in Baltimore, Maryland. This event features 175+ industry, regulatory and biosimilar professionals gaining insight into analytical characterization and comparability for change implementation through case studies, interactive break-out discussions, networking opportunities and more!

Conference Programs:

• Post-Translational Modifications
  Identification, Characterization, Impact and Control
  
  
• Analytical Characterization of Biotherapeutics
  Advanced technologies, structure and function, novel products, particulates, and regulatory standards
  
  
• Comparability and Developability
  The Interface between Analytical Characterization, Process Development and Regulatory Approval for Innovators and Biosimilars

Speakers include:

• Shantha T. Raju, Ph.D., Scientific Director, Biologics Research, Centocor, Inc.
• Hongchen Liu, Ph.D., Scientist, Process Development, Alexion Pharmaceuticals
• Patricia W. Cash, Ph.D., Senior Director, Analytical Biochemistry, MedImmune, Inc.
• Dirk Chelius, Ph.D., Fellow, Biologics Research & Development, Novartis Pharma AG
• Yung-Hsiang Kao, Ph.D., Principal Scientist and Senior Group Leader, Late Stage Pharmaceutical Development, Genentech, Inc.
• Hongling Han, Ph.D., Senior Scientist, Integrated Biologics Profiling, Novartis, Inc.
• Hubert Kettenberger, Principal Scientist, Pharma Research and Early Development (pRED), Roche Diagnostics
• Zhirui (Jerry) Lian, Ph.D., Senior Research Scientist and Group Leader, Bioproducts Research & Development, Eli Lilly and Company
• Bing Gong, Ph.D., Associate Principal Scientist, GlycoFi Biologics Discovery
• Jeffrey W. Hudgens, Ph.D., Research Chemist, Institute for Bioscience and Biotechnology Research,Biomolecular Measurement Division, National Institute of Standards and Technology
• Dietmar Reusch, Ph.D., Director, Pharma Development, Analytics Pharma Biotech Production & Development Characterization, Roche Diagnostics GmbH
• Qinwei Zhou, Ph.D., Vice President, BioAnalytical Sciences, ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company
• David Spencer, B.Sc., Scientist II, Biopharmaceutical Development, MedImmune LLC
• Niclas Tan, Ph.D., Scientist II, Analytical Development – Biologics, Takeda Pharmaceuticals International Co.
• Alain Beck, Ph.D., Senior Director, Antibody Physico-Chemistry, Centre d’Immunologie Pierre Fabre and Associate Editor, mAbs
• Bridget Carragher, Ph.D., Integrative Structural and Computational Biology, Scripps Research Institute
• Randall Burton, Ph.D., Senior Scientist, Process Sciences, AbbVie, Inc.
• Qin Zou, Ph.D., Senior Principal Scientist, Analytical Research and Development, Pfizer, Inc.
• Samadhi Vitharana, Ph.D., Senior Scientist, Core Sciences & Technologies, Takeda California, Inc.
• Michael Fleming, MS, Scientist III, Analytical & Pharmaceutical Sciences, ImmunoGen, Inc.
• Melissa Alvarez, MS, Senior Research Associate, Protein Analytical Chemistry, Genentech, Inc., a member of the Roche group
• Jeffrey D. Meyer, Ph.D., Director, BioProcess Development, ZymoGenetics (a Bristol-Meyers Squibb Company)
• Bjoern Boll, Pharma Technical Development Europe (Biologics) Analytics, F. Hoffmann-La Roche Ltd.
• Flaviu F. Gruia, Ph.D., Scientist, Analytical Biotechnology, MedImmune, Inc.
• Li Zang, Senior Scientist, Analytical Development, Biogen Idec, Inc.
• John O'Hara, Ph.D., Director, Characterization & Method Development, Analytical Sciences, Biologicals, UCB
• Tam Soden, Ph.D., Director, Analytical Development, Johnson & Johnson
• David Cirelli, Ph.D., Research Scientist, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.
• Ling Gu, Ph.D., Pfizer
• Tom Lerch, Ph.D., Senior Scientist, Analytical Research & Development, Pfizer, Inc.
• John P. Gabrielson, Ph.D., Principal Scientist, Analytical Sciences, Amgen, Inc.
• Jeffrey K. Glenn, Ph.D., Associate Director, Analytical Development, Johnson & Johnson
• Kazumi Kobayashi, Ph.D., Director, Bioprocess Development, Biogen Idec, Inc.
• Laxmi Adhikary, Ph.D., Principal Scientific Manager, Research & Development, Biocon Ltd.
• John Stults, Ph.D., Director, Protein Analytical Chemistry, Genentech, Inc.
• Shanthini Jeyarajah, Ph.D., Associate Director, Biological Analytical Development, AVEO-Oncology
• Lixin Xu, Ph.D., Monoclonal Antibodies, Biotechnology, FDA/CDER
• Tina S. Morris, Ph.D., Vice President, Biologics & Biotechnology, USP
• Robert Mayer, Ph.D., Scientist, Analytical Characterization, Sandoz GmbH
• Randal Bas, Ph.D., Principal Scientist, Amgen, Inc.
• Kenneth R. Miller, Ph.D., Senior Scientist, Analytical Biotechnology - Sciences & Strategy, MedImmune, Inc.
• Zahra Shahrokh, Ph.D., CSO, STC Biologics
• Amy Hilderbrand, Ph.D., Scientist, Protein Analytical Chemistry, Genentech, Inc.
• Christopher J. Holloway, Ph.D., Group Director, Regulatory Affairs & CSO, ERA Consulting Group
• Emily Shacter, Ph.D., Consultant, ThinkFDA